SCIPA Full-On :Intensive Exercise Program After Spinal Cord Injury

Spinal Cord Injury Clinical Trial

— SCIPAFull-On  

Official title:

SCIPA Full-On :Intensive Exercise Program After Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01236976
• Other study ID #: SCIPA Full-On
• Status: Completed
• Phase: Phase 3
• Start date: December 2010
• Est. completion date: June 2016

Study information

• Verified date: April 2021
• Source: University of Melbourne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is a multi-centre, assessor-blind, randomised controlled phase III trial in patients with with complete or incomplete spinal cord injury between C6 and T12. A total of 188 participants will be randomised into two groups, the experimental group and the control group. The control group participants will receive an upper body strength and fitness program, conducted for 2-3 hours, three times per week for 12 weeks, while the experimental group participants will receive a comprehensive full body exercise program, conducted for 2-3 hours, three times per week for 12 weeks. The main objective of this study is to determine if the experimental exercise program is more effective than the upper body strength and fitness program in promoting neurological improvement in participants with spinal cord injury. Total study duration is 3.5 years, including a 24 month recruitment period, a 12-week treatment period followed by 6 month and 12 month (from baseline) follow up assessments. Participants will be assessed by a blinded assessor (the assessor will not know which group the participants are in) using standard physiotherapy, neurophysiological, fitness and functional tests, psychological and quality of life questionnaires, as well as tests of immune function and bone structure.

Description:

The study is a multi-centre, assessor-blind, randomised controlled phase III trial in patients with with complete or incomplete spinal cord injury between C6 and T12. A total of 188 participants will be randomised into two groups, the experimental group and the control group. The control group participants will receive an upper body strength and fitness program, conducted for 2-3 hours, three times per week for 12 weeks, while the experimental group articipants will receive a comprehensive full body exercise program, conducted for 2-3 hours, three times per week for 12 weeks. The main objective of this study is to determine if the experimental exercise program is more effective than the upper body strength and fitness program in promoting neurological improvement in participants with spinal cord injury. Total study duration is 3.5 years, including a 24 month recruitment period, a 12-week treatment period followed by 6 month and 12 month (from baseline) follow up assessments. Participants will be assessed by a blinded assessor (the assessor will not know which group the participants are in) using standard physiotherapy, neurophysiological, fitness and functional tests, psychological and quality of life questionnaires, as well as tests of immune function and bone structure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: June 2016
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Have sustained a traumatic spinal cord injury a minimum of 6 months prior to consent and have completed their primary rehabilitation

2. Are 18 years or older and able to give informed consent

3. Have a complete or incomplete spinal cord injury between C6 and T12 (as per the International Standardised Neurological Assessment for SCI)

4. Are able and willing to attend an exercise program 3 times per week for 12 weeks

5. Are considered by their medical consultant to be fit to undertake the exercise program (documented approval by medical consultant required).

Exclusion Criteria:

1. Have brachial plexus, cauda equina, or peripheral nerve injury

2. Have had recent major trauma or surgery within the last 6 months

3. Have an existing pressure ulcer Stage 3 or 4 according to the National Pressure Ulcer Advisory Panel classification

4. Are post-menopausal at time of injury (females)

5. Have BMI at injury falling below lower threshold of healthy adult reference range

6. Have endocrinopathy or metabolic disorders of bone, such as Paget's disease, lytic or renal bone disease and senile osteoporosis

7. have medical history of exposure to medication(s) known to affect mineral ion or bone metabolism

8. Have chronic systemic diseases, e.g. Hep C, HIV-AIDs

9. Have significant impairment or disability, including physical, neurological or psychological impairments

10. Have a history of long bone fracture, or family history of fragility fracture

11. Have medical fragility, e.g. BMI falling below lower threshold of healthy adult reference range, or history of recurrent hospital readmissions.

12. Have extensive fixed contractures in upper or lower limbs

13. Have severe spasticity

14. Have uncontrolled neuropathic pain

15. Are likely to experience clinically significant autonomic dysreflexia and/or hypotension in response to electrical stimulation or prolonged upright posture

16. Are unable to attend the 6-month and 12 month follow-up assessments at their treating spinal unit

17. Have any contraindications to FES such as cardiac pacemaker, epilepsy, lower limb fracture or pregnancy

18. Have intracranial metal implants (for TMS only)

19. Have any other serious medical condition including malignancies, psychiatric, behavioural or drug-dependency problems, which are likely to influence the participant's ability to cooperate or in the opinion of the study investigator would prevent adherence to the Protocol.

20. Are participating in any other therapy (including alternative therapies) or taking medications (including herbal preparations) that are not considered to be standard care as per the protocol.

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Device:
• Therastride Treadmill System
This device supports spinal cord injured patients to stand (suspended in a harness by an overhead pulley) on the specially designed treadmill for locomotor training. It is registered with the FDA (Regulation Number 890.5380).
• FES-assisted cycling
This intervention will be provided using a RT300 cycle (Restorative Therapies, Baltimore MD).

Other:
• Trunk and upper and lower limb exercises
This intervention will comprise assisted and/or resisted movements aimed at facilitating and strengthening voluntary muscle activity and improving movement quality.
• Upper body strength and fitness program
This intervention is a circuit-based exercise program incorporating resistance and cardiovascular training.

Locations

Country	Name	City	State
Australia	Victorian Spinal Cord Injury Service, Royal Talbot Rehabilitation Centre	Kew	Victoria
Australia	South Australian Spinal Cord Injury Service, Hampstead Rehabilitation Centre	Northfield	South Australia
Australia	Spinal Unit, Prince of Wales Hospital	Randwick	New South Wales
Australia	Sir George Bebrook Spinal Injuries Centre, Royal Perth Hospital	Shenton Park	Western Australia
Australia	Royal Rehabilitation Centre Sydney	Sydney	New South Wales
New Zealand	Burwood Academy	Christchurch

Sponsors (7)

Lead Sponsor	Collaborator
University of Melbourne	Austin Health, Burwood Hospital, Christchurch, New Zealand, Hampstead Rehabilitation Centre Adelaide, Prince of Wales Hospital, Sydney, Royal Rehabilitation Centre Sydney, Shenton Park Rehabilitation Centre Perth

Countries where clinical trial is conducted

Australia,  New Zealand, 

References & Publications (2)

Galea MP, Dunlop SA, Davis GM, Nunn A, Geraghty T, Hsueh YS, Churilov L. Intensive exercise program after spinal cord injury ("Full-On"): study protocol for a randomized controlled trial. Trials. 2013 Sep 11;14:291. doi: 10.1186/1745-6215-14-291. — View Citation

Galea MP, Dunlop SA, Geraghty T, Davis GM, Nunn A, Olenko L, and SCIPA Full-On Trial Collaborators. SCIPA Full-On: A randomized contolled trial comparing intensive whole-body exercise and upper body exercise after spinal cord injury. Neurorehabilitation a

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the relative effectiveness of a comprehensive exercise program compared to a generic upper body strength and fitness training program on neurological improvement.		12 weeks